Treatment of herpes labialis by photodynamic therapy: Study protocol clinical trial (SPIRIT compliant)

Andreia La Selva, Renata Matalon Negreiros, Daniela Teixeira Bezerra, Ellen Perin Rosa, Vanessa Christina Santos Pavesi, Ricardo Scarparo Navarro, Marina Stella Bello-Silva, Karen Müller Ramalho, Ana Cecília Corrêa Aranha, Paulo Henrique Braz-Silva, Kristianne Porta Santos Fernandes, Sandra Kalil Bussadori, Anna Carolina Ratto Tempestini Horliana, Andreia La Selva, Renata Matalon Negreiros, Daniela Teixeira Bezerra, Ellen Perin Rosa, Vanessa Christina Santos Pavesi, Ricardo Scarparo Navarro, Marina Stella Bello-Silva, Karen Müller Ramalho, Ana Cecília Corrêa Aranha, Paulo Henrique Braz-Silva, Kristianne Porta Santos Fernandes, Sandra Kalil Bussadori, Anna Carolina Ratto Tempestini Horliana

Abstract

Background: Lesions of herpes labialis are caused by the herpes simplex virus type 1 and cause pain and aesthetic compromise. It is characterized by the formation of small vesicles that coalesce and rupture forming extremely painful ulcers, that evolve to crusts, dry desquamations until their complete remission. Currently the treatment of these lesions is done with acyclovir. Although it diminishes the symptomatology, it causes viral resistance and does not prevent the recurrence of the lesions. It is known that antimicrobial photodynamic therapy (aPDT) has numerous advantages, among them: the reduction of the time of remission, and does not cause resistance. This protocol will determine the effectiveness of PDT in lesions of herpes labialis.

Materials and methods: A total of 30 patients with herpes labialis in the prodromal stage of vesicles, ulcers, and crusts will be selected to participate in the study and randomized into 2 groups: G1 control and G2 experimental. After signing Research Ethics Committee and TA, patients in group G1 will undergo the standard gold treatment for herpes labialis with acyclovir and simulated PDT treatment. Patients in the experimental G2 group will be treated simulating the gold standard treatment of herpes labialis (placebo) and PDT. In all patients, saliva samples will be collected for analysis of cytokines, and will be performed exfoliative cytology in the lesions. The pain will be assessed through a pain scale and a questionnaire of quality of life related to oral health (OHIP-14) will be given to them. Patients will continue to be followed up after 7 days, 1 month, 3 months, and 6 months; if there is a recurrence of the lesion, they will contact the researchers.Clinical registration: clinicaltrials.gov - NCT04037475. Registered on July 2019.

Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
Flowchart. REC = Research Ethics Committee, ICF = Informed Consent Form, OHIP-14 = Oral Health Impact Profile Questionnaire, VHS = virus Herpes Simplex, PDT = photodynamic therapy.

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